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UNIVERSITATEA DE MEDICIN I FARMACIE IULIU HAIEGANU CLUJ-NAPOCA

FACULTATEA DE FARMACIE DISCIPLINA DE ORGANIZARE I LEGISLAIE

FARMACEUTIC

RSPUNDEREA PENAL N DOMENIUL FARMACEUTIC

REZUMATUL TEZEI DE DOCTORAT

Conductor tiinific Doctorand Prof. dr. Constantin Polinicencu Farm. Anamaria Murean

2010

CUPRINS

INTRODUCERE....................................................................................................4

I. PARTEA GENERAL. RSPUNDEREA JURIDIC .................................6

CAPITOLUL 1 NOIUNEA DE RSPUNDERE ....................................................................6

1. 1. Definirea i formele rspunderii .............................................................6 1. 2. Condiiile rspunderii .............................................................................7 1. 3. Concluzii.................................................................................................9

CAPITOLUL 2 RSPUNDEREA PENAL ...........................................................................10

2. 1. Definirea rspunderii penale.................................................................10 2. 2. Principiile rspunderii penale ...............................................................12 2. 3. Infraciunea...........................................................................................18

2. 3. 1. Trsturi eseniale i generale ale infraciunii ........................19 2. 3. 2. Elementele infraciunii............................................................20

2. 4. Sanciunea.............................................................................................25 2. 5. Executarea sanciunilor penale .............................................................27

2. 5. 1. Executarea pedepselor principale ...........................................28 2. 5. 2. Executarea pedepselor complimentare ...................................30 2. 5. 3. Executarea pedepselor accesorii .............................................30

2. 6. Concluzii...............................................................................................30

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CAPITOLUL 3 REABILITAREA I CAUZELE CARE NLTUR RSPUNDEREA PENAL.........................................32

3. 1. Reabilitarea...........................................................................................32 3. 1. 1. Reabilitarea de drept ...............................................................33 3. 1. 2. Reabilitarea judectoreasc ....................................................34

3. 2. Cauzele care nltur rspunderea penal.............................................35 3. 2. 1. Amnistia..................................................................................36 3. 2. 2. Graierea .................................................................................37 3. 2. 3. Prescripia ...............................................................................38 3. 2. 4. Lipsa plngerii prealabile i mpcarea prilor......................38

3. 3. Concluzii...............................................................................................39

II. CONTRIBUII PERSONALE RSPUNDEREA PENAL N DOMENIUL FARMACEUTIC ...................40

A. IPOTEZA DE LUCRU...................................................................................40 CAPITOLUL 4 PROBLEME N PRACTICA FARMACEUTIC ......................................40

4. 1. Probleme care necesit reglementare ...................................................42 4. 2. Probleme care necesit modificri ale normelor n vigoare .................47 4. 3. Probleme de aplicare a normelor n vigoare.........................................48 4. 4. Concluzii...............................................................................................49

B. MATERIALE I METODE...........................................................................50 CAPITOLUL 5 LEGISLAIA FARMACEUTIC I METODELE JURIDICE ..............50

5. 1. Materiale ...............................................................................................50 5. 2. Metode ..................................................................................................54

5. 2. 1. Metode de cercetare juridic...................................................55 5. 2. 1. 1. Metoda logic ........................................................55 5. 2. 1. 2. Metoda comparativ ..............................................55 5. 2. 1. 3. Metoda istoric ......................................................56 5. 2. 1. 4. Metoda sociologic ................................................57

5. 2. 2. Interpretarea juridic...............................................................58 5. 2. 2. 1. Metoda gramatical................................................58 5. 2. 2. 2. Metoda sistematic ................................................59 5. 2. 2. 3. Metoda logic ........................................................61 5. 2. 2. 4. Metoda teleologic.................................................62 5. 2. 2. 5. Metoda istoric ......................................................63

5. 3. Concluzii...............................................................................................64

C. REZULTATE I DISCUII INFRACIUNI PRIVIND REGIMUL LEGAL AL EXERCITRII PROFESIUNII DE FARMACIST.................................................................................................65

CAPITOLUL 6 EXERCITAREA FR DREPT A PROFESIUNII DE FARMACIST....67

6. 1. Eliberarea din drogherii a medicamentelor etice..................................79 6. 2. Funcionarea fr farmacist a unitilor farmaceutice ..........................85

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6. 3. Exercitarea profesiunii de farmacist n afara unitii farmaceutice......86 6. 4. Concluzii...............................................................................................89

CAPITOLUL 7 INTERDICII DE EXERCITARE A PROFESIUNII DE FARMACIST.............................................................91

7. 1. Infraciuni contra umanitii sau vieii..................................................91 7. 1. 1. Infraciuni contra pcii i omenirii .........................................93 7. 1. 2. Infraciuni contra vieii ...........................................................97

7. 2. Alte infraciuni care pot conduce la interzicerea exercitrii profesiunii de farmacist ........................................................99 7.3. Suspendarea sau retragerea calitii de membru al Colegiului Farmacitilor din Romnia ..................................................................105 7. 4. Concluzii.............................................................................................110

CAPITOLUL 8 INCOMPATIBILITI CU EXERCITAREA PROFESIUNII DE FARMACIST...............................................................111

8. 1. Difuzarea i comercializarea altor produse n afara celor nregistrate i aprobate de Ministerul Sntii ............112 8. 2. Exercitarea profesiunii de medic ........................................................113 8. 3. Ocupaii de natur a aduce atingere demnitii profesiunii de farmacist sau bunelor moravuri ...................................117 8. 4. Starea de sntate necorespunztoare.................................................118 8. 5. Incompatibiliti prevzute de Codul deontologic al farmacistului....119 8. 6. Concluzii.............................................................................................123

III. CONCLUZII FINALE................................................................................126

REFERINE ......................................................................................................134

Cuvinte cheie: rspunderea penal, farmacist, profesiune, infraciune, interdicie, incompatibilitate.

INTRODUCERE

Lucrarea are ca scop studierea rspunderii penale n domeniul farmaceutic n Romnia. Am ales tema lucrrii de fa ntruct infraciunea n domeniul farmaceutic este ndreptat mpotriva celei mai importante valori sociale ocrotite de ctre stat prin normele de drept i anume sntatea. Misiunea farmacistului este de a ocroti sntatea, de a ajuta la redobndirea ei, iar comind o infraciune n acest domeniu nseamn a aciona n sens opus misiunii sale profesionale. Pentru realizarea scopului lucrrii, este necesar analiza condiiilor legale de exercitare a profesiunii de farmacist, a regimului legal general al medicamentelor i a regimului legal special al drogurilor. Studiul de fa se refer, n special, la rspunderea penal legat de condiiile de exercitare a profesiunii de farmacist.

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I. PARTEA GENERAL. RSPUNDEREA JURIDIC

Capitolul 1 Noiunea de rspundere

Fiecare ramur a dreptului cunoate o form de rspundere specific caracterizat prin condiii specifice de fond i de form (condiii, mod de stabilire, forme de realizare, sanciuni). Exist astfel mai multe forme de rspundere juridic: rspunderea juridic cu caracter politic (rspunderea constituional a parlamentului), rspunderea civil, rspunderea penal, rspunderea administrativ (rspunderea puterii publice), rspunderea disciplinar, rspunderea internaional.

Condiiile rspunderii juridice sunt: conduita ilicit, vinovia i legtura cauzal ntre fapta ilicit i prejudiciul produs.

Capitolul 2 Rspunderea penal

Dreptul penal, n totalitate, este structurat n jurul a trei instituii fundamentale: infraciunea, rspunderea penal i pedeapsa.

Rspunderea penal reprezint raportul juridic penal de constrngere, nscut ca urmare a svririi unei infraciuni, ntre stat, pe de o parte, i infractor, pe de alt parte. Acesta este un raport complex, al crui coninut formeaz dreptul statului, ca reprezentant al societii, de a trage la rspundere pe infractor, de a-i aplica sanciunea prevzut pentru infraciunea svrit i de a-l constrnge s o execute, precum i obligaia infractorului de a rspunde pentru fapta sa i de a se supune sanciunii, n vederea restabilirii ordinii de drept i restaurrii autoritii legii.

Temeiul rspunderii penale este infraciunea - fapta ce reprezint un grad nalt de pericol social, svrit cu vinovie i prevzut de legea penal. Elementele ei sunt: obiectul, subiectul, latura obiectiv i cea subiectiv. Executarea sanciunilor penale are loc prin punerea efectiv a condamnatului s nfptuiasc coninutul acestor sanciuni.

Capitolul 3 Reabilitarea i cauzele care nltur rspunderea penal

Condamnarea poate avea unele consecine i dup executarea pedepsei principale, restrngnd capacitatea juridic a fotilor condamnai (decderi, interdicii i incapaciti), care ns se pot stinge dup scurgerea unui interval de timp, prin reabilitare. Astfel, reabilitarea constituie un stimulent pentru fotii condamnai de a avea o conduit corespunztoare cerinelor societii, dovedit prin aceea c nu au mai nclcat legea. Prin reabilitare, fostul condamnat este reintegrat n societate, i din punct de vedere moral, nu doar juridic. Cauzele care nltur rspunderea penal sunt: amnistia, graierea, prescripia, lipsa plngerii prealabile, mpcarea prilor i retragerea plngerii prealabile. Aceste cauze sunt generale, deoarece privesc n principiu orice infraciune. Unele au efect numai n baza dispoziiilor din Codul penal, pe cnd altele, presupun i intervenia organelor supreme ale puterii de stat, n anumite cazuri (amnistia i graierea).

II. CONTRIBUII PERSONALE RSPUNDEREA PENAL N DOMENIUL FARMACEUTIC

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A. IPOTEZA DE LUCRU

Rspunderea penal n domeniul farmaceutic este angajat n urma nerespectrii regimului de exercitare a profesiunii de farmacist i a regimului legal al medicamentelor. Iniial, la nceperea acestui studiu, s-a ncercat analizarea ambelor situaii. Pe parcurs ns, pentru a menine scopul i funcionalitatea lucrrii, s-a considerat limitarea cercetrii doar la prima situaie. Prin urmare, obiectivele acestui studiu sunt:

- prezentarea rspunderii juridice n cadrul legislaiei romneti; - definirea rspunderii penale i a principiilor care o guverneaz; - prezentarea cadrului legal de exercitare a profesiunii de farmacist; - stabilirea normelor legale, adecvate cercetrii propuse, care duc la naterea

rspunderii penale n domeniul farmaceutic, n special a celor de exercitare a profesiunii de farmacist;

- analizarea textului acestor norme pentru stabilirea cazurilor n care este angajat rspunderea penal, ca urmare a nerespectrii regimului legal de exercitare a profesiunii de farmacist;

- studierea interdiciilor i a incompatibilitilor de exercitare a profesiunii de farmacist;

- identificarea condiiilor i a cauzelor exercitrii fr drept a profesiunii de farmacist;

- analizarea situaiilor din practic de exercitare fr drept a profesiunii de farmacist;

- identificarea i analizarea deficienelor textului legilor studiate, a problemelor de aplicabilitate ale acestor norme, a discordanelor ntre diferite acte normative care reglementeaz domeniul farmaceutic, dar i a neconcordanelor ntre prevederile actelor normative i necesitile din practic;

- mpiedicarea repetrii problemelor examinate, n normele viitoare.

Capitolul 4 Probleme n practica farmaceutic

Problemele legislative n domeniul farmaceutic romnesc pot clasificate n trei mari categorii i anume: probleme care necesit reglementare, probleme care necesit modificri ale normelor n vigoare i probleme de aplicare a normelor n vigoare. Printre problemele majore din practica n domeniul farmaceutic ce necesit reglementare se numr: lipsa definirii exacte a profesiunii de farmacist, a proprietii asupra unitilor farmaceutice i a standardelor de funcionare a unitilor farmaceutice.

Problemele ce necesit modificri ale legislaiei n vigoare, referitoare la practica n domeniul farmaceutic, sunt multiple. O parte sunt date de existena unor norme contrare n cuprinsul aceleai legi sau n alte prevederi legale (ca de exemplu art. 634 cu art. 836 din Legea nr. 95/2006), unele deriv din inexistena n legislaie a trimiterilor prevzute (ca de exemplu art.562 din Legea nr. 95/2006), iar altele nu-i au corespondena sau reciprocitatea n legislaia n vigoare (ca de exemplu art. 563 alin. 1 lit. a i art. 383 lit. a din Legea nr. 95/2006). Problemele de aplicare a legislaiei farmaceutice n vigoare sunt date de: inexistena unor standarde clare de exercitare a profesiunii de farmacist i de operare a unitilor farmaceutice, de modificrile mult prea dese, din ultimul timp, a legislaiei farmaceutice i de greutatea aplicrii normelor farmaceutice n vigoare privitoare la controlul acestei activiti. Lucrarea de fa are ca scop studierea normelor referitoare la rspunderea penal

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n domeniul farmaceutic, cu privire special la exercitarea profesiunii de farmacist i prentmpinarea apariiei problemelor legislative observate i discutate ntr-o norm legal ulterioar.

B. MATERIALE I METODE

Capitolul 5 Legislaia farmaceutic i metodele juridice

Pentru cercetarea propus s-au studiat textele de lege privind exercitarea profesiunii de farmacist, organizarea i funcionarea Colegiului Farmacitilor din Romnia, Codul deontologic al farmacistului i Codul penal al Romniei.

Cercetarea n domeniul legislaiei farmaceutice reclam utilizarea metodologiei juridice, adic a metodelor folosite n cercetarea tiinific n domeniul dreptului. Sunt prezentate metodele de cercetare juridic utilizate, cu detalierea metodelor logice, comparative, istorice i sociologice. Pentru studiul propus s-a aplicat interpretarea juridic. Ea cuprinde mai multe categorii de metode i anume: interpretarea gramatical, teleologic, sistematic, istoric i logic. n general, n lucrarea de fa aceste metode de interpretare juridic nu au fost folosite izolat, ci s-au utilizat mpreun, fie cte dou sau mai multe sau toate n acelai timp, pentru stabilirea adevratului sens i scop ale normelor studiate.

C. REZULTATE I DISCUII INFRACIUNI PRIVIND REGIMUL LEGAL AL EXERCITRII PROFESIUNII

DE FARMACIST

Capitolul 6 Exercitarea fr drept a profesiunii de farmacist

Analiza contextului legal de exercitare a profesiunii de farmacist a dus att la identificarea condiiilor n care se svrete infraciunea de exercitare fr drept a profesiunii de farmacist, ct i la observarea cauzelor svririi acestei infraciuni. Condiiile existenei acestei infraciuni sunt legate de svrirea de acte rezervate profesiunii de farmacist de ctre o persoan care nu are aceast calitate (art. 40 din Legea nr. 81/1997, art. 78 din Legea nr. 305/2004, art. 634 din Legea nr. 95/2006 i art. 281 din Codul penal). Situaiile din practic de exercitare fr drept a profesiunii de farmacist sunt: - eliberarea din drogherii a altor medicamente dect cele fr prescripie medical; - funcionarea farmaciei sau a depozitului de medicamente fr farmacist; - exercitarea profesiunii de farmacist de ctre o persoan care nu are aceast calitate. Cele mai frecvente situaii de exercitare fr drept a profesiunii de farmacist, ntlnite n practic, sunt cele n care asistenii de farmacie, n drogherii, ncalc prevederile legale de eliberare a medicamentelor din grupa A. Persoanele vinovate de complicitate la infraciunea de exercitare fr drept a profesiunii de farmacist sunt, cel mai frecvent, chiar farmaciti. Cauzele exercitrii fr drept a profesiunii de farmacist sunt: - lipsa definirii exacte, ntr-un act normativ, a profesiunii de farmacist i a celei de

asistent de farmacie, a atribuiilor, ndatoririlor i competenelor profesionale ale acestora;

- lipsa prevederilor legale, clare, privind farmacistul stagiar; - organizarea i funcionarea necorespunztoare a Inspeciei de Farmacie, n privina

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controlului respectrii condiiilor legale i a sanciunilor legale aplicabile; - ineficiena activitii Colegiul Farmacitilor din Romnia n privina respectrii, de

ctre farmaciti, a Codului deontologic al farmacistului; - lipsa contiinei profesionale n cazul unor farmaciti.

Considernd caracteristicile ce definesc profesiunea i valorile sociale aprate de stat, se poate deduce importana respectrii prevederilor legale privitoare la exercitarea profesiunii de farmacist, pentru c infraciunea de exercitare ilegal a profesiunii de farmacist, de ctre o persoan care nu are aceast calitate sau de orice alt persoan, n alte condiii dect cele legale, poate duce, nu doar la periclitarea valorilor sociale pe care le apar legea prin incriminarea unei astfel de fapte, dar i la compromiterea prestigiului profesiunii ce st la baza autonomiei exercitrii profesiunii de farmacist i a privilegiului de auto-reglementare.

Capitolul 7 Interdicii de exercitare a profesiunii de farmacist

Pedeapsa interzicerii exercitrii profesiunii de farmacist a fost prevzut succesiv de art. 5 din Legea nr. 81/1997, art. 10 din Legea nr. 305/2004 i art. 562 din Legea nr. 95/2006. Aceast pedeaps poate fi aplicat farmacistului de ctre organizaia profesional ca sanciune disciplinar sau de ctre instana de judecat ca urmare a condamnrii definitive pentru svrirea cu intenie a unei infraciuni contra umanitii sau vieii n mprejurri legate de exercitarea profesiunii de farmacist, ca pedeaps complementar (potrivit art. 53 pct. 2 lit. a, art. 64 lit. c, art. 65 i art. 66 din Codul penal) pentru orice infraciune pentru care pedeapsa principal aplicat este de minim doi ani, ca pedeaps accesorie (potrivit art. 64 lit. c i art. 71 lit. b din Codul penal) n cazul oricrei condamnri privative de libertate, ca msur de siguran (art. 111, 112, 115 din Codul penal) pentru orice infraciune chiar dac nu s-a aplicat nici o pedeaps sau ca urmare a contestrii n instan a deciziilor luate de organizaia profesional.

Aplicarea pedepsei interzicerii exercitrii profesiunii farmacistului, aflat n una din situaiile prezentate n lucrare, este pe deplin justificat deoarece fapta acestuia prezint un pericol social crescut, periclitnd valorile sociale i ordinea de drept, acionnd n sens opus scopului nsui al farmacistului, de ocrotire a sntii i vieii omului.

Capitolul 8 Incompatibiliti cu exercitarea profesiunii de farmacist

Incompatibilitile cu exercitarea profesiunii de farmacist au fost prevzute succesiv de art. 6 alin. 1 i 2 al Legii nr. 81/1997, art. 11 alin. 1 al Legii nr. 305/2004 i art. 563 alin. 1 al Legii nr. 95/2006.

n legislaia actual, conform n art. 563 alin. 1 al Legii nr. 95/2006, exercitarea profesiunii de farmacist este incompatibil cu: profesia de medic, oricare ocupaie de natur a aduce atingere demnitii profesiei de farmacist sau bunelor moravuri, iar conform Codului deontologic al farmacistului, cu starea de sntate fizic sau psihic necorespunztoare, pentru exercitarea profesiei de farmacist.

Incompatibilitatea ntre exercitarea profesiunii de farmacist i cea de medic, prevzut de Legea nr. 95/2006 ar trebui reformulat astfel nct s stabileasc norme coerente pentru necesitile din practic. Dei nu este prevzut n Legea nr. 95/2006 i

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nici nu a fost prevzut n legile precedente, cel mai frecvent caz de incompatibilitate rmne, n continuare, acela n care o persoan care exercit profesiunea de medic are, n acelai timp, calitatea de proprietar al unei uniti farmaceutice. Pentru a preveni nclcarea dreptului pacientului de a-i alege farmacia, ar trebui modificate prevederile legale, n sensul recunoaterii acestei incompatibiliti.

Incompatibilitatea cu orice alt profesiune sau ocupaie de natur a aduce atingere demnitii profesiunii de farmacist sau bunelor moravuri, prevzut de art. 563 alin. 1 lit. b al Legii nr. 95/2006, este justificat i se datoreaz unor trsturi ce deriv din aceste profesiuni sau ocupaii, care ar prejudicia relaia cu pacientul, fie prin scderea ncrederii pacientului n farmacist, fie printr-o atitudine contrar ocrotirii sntii.

Incompatibilitatea exercitrii profesiunii de farmacist cu starea de sntate fizic sau psihic necorespunztoare a farmacistului pentru exercitarea profesiunii, prevzut de art. 563 alin. 1 lit. c al Legii nr. 95/2006 deriv, n acest caz, pe de o parte, din faptul c o stare necorespunztoare a sntii pentru persoana n cauz duce la nendeplinirea prevederilor legale pentru valabilitatea Certificatului de membru al Colegiului Farmacitilor din Romnia (art. 564 alin. 3 lit. b al Legii nr. 95/2006) i a condiiilor legale de exercitare a profesiunii (art. 560 alin. 1 lit. c al Legii nr. 95/2006), iar pe de alt parte, o stare necorespunztoare a sntii pune sub semnul ntrebrii capacitatea farmacistului de a-i exercita corect profesiunea n folosul pacienilor. O problem, n acest sens, este reprezentat de lipsa, n legislaia n vigoare, a unei proceduri de lucru pentru sesizarea experilor, pentru expertizarea propriu-zis i pentru emiterea deciziei de suspendare sau retragere a dreptului de a exercita profesiunea de farmacist pentru farmacistul n cauz.

Cauzele de apariie a incompatibilitilor sunt: - lipsa unor prevederi legale speciale privind proprietatea asupra unitilor

farmaceutice; - funcionarea necorespunztoare a organelor specializate ale Ministerului Sntii i

ale organizaiilor profesionale implicate, n privina controlului respectrii condiiilor legale i a sanciunilor legale aplicabile;

- deficiene n respectarea eticii profesionale medicale i farmaceutice. Prevederile art. 37 lit. c, e i f din Codul deontologic al farmacistului, ar trebui

reformulate sau abrogate, pentru a fi n acord cu legislaia farmaceutic actual.

III. CONCLUZII FINALE

Lucrarea de fa are ca scop studierea normelor referitoare la rspunderea penal n domeniul farmaceutic, cu privire special asupra exercitrii profesiunii de farmacist. Ipoteza de lucru o constituie problemele legislative n domeniul farmaceutic, care pot clasificate n trei mari categorii: probleme care necesit reglementare, probleme care necesit modificri ale normelor n vigoare i probleme de aplicare a normelor n vigoare. Pentru cercetarea propus s-au studiat textele legale i reglementare urmtoare: Legea nr. 81/1997 privind exercitarea profesiunii de farmacist, nfiinarea, organizarea i funcionarea Colegiului Farmacitilor din Romnia, Legea nr. 305/2004 privind exercitarea profesiunii de farmacist, precum i organizarea i funcionarea Colegiului Farmacitilor din Romnia, Legea nr. 95/2006 privind reforma n domeniul sntii, Titlul XIV Exercitarea profesiunii de farmacist, organizarea i funcionarea Colegiului Farmacitilor din Romnia, Codul deontologic al farmacistului i Codul penal. Cercetarea n domeniul legislaiei farmaceutice reclam utilizarea metodologiei juridice, din care s-au utilizat n special metodele interpretrii juridice i metoda

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comparativ. Aceste metode s-au aplicat asupra prevederilor legale referitoare la exercitarea fr drept a profesiunii de farmacist, interzicerea exercitrii profesiunii de farmacist i incompatibiliti cu exercitarea profesiunii de farmacist. Situaiile din practic de exercitare fr drept a profesiunii de farmacist sunt: eliberarea din drogherii a altor medicamente dect cele fr prescripie medical; funcionarea farmaciei sau a depozitului de medicamente fr farmacist; exercitarea profesiunii de farmacist de ctre o persoan care nu are aceast calitate. Cauzele exercitrii fr drept a profesiunii de farmacist sunt: lipsa definirii exacte ntr-un act normativ a profesiunii de farmacist i a celei de asistent de farmacie, a atribuiilor, ndatoririlor i competenelor profesionale ale acestora; lipsa prevederilor legale clare privind farmacistul n stagiu; organizarea i funcionarea necorespunztoare a inspeciei de farmacie, n privina controlului respectrii condiiilor legale i a sanciunilor legale aplicabile; ineficiena activitii Colegiul Farmacitilor, n privina respectrii, de ctre farmaciti, a Codului deontologic; lipsa contiinei profesionale n cazul unor farmaciti. Pedeapsa interzicerii exercitrii profesiunii de farmacist poate fi aplicat farmacistului de ctre organizaia profesional ca sanciune disciplinar sau de ctre instana de judecat. Ea este obligatoriu de aplicat de ctre instan, n cazul condamnrii definitive pentru svrirea cu intenie a unei infraciuni contra umanitii sau vieii n mprejurri legate de exercitarea profesiunii de farmacist. Ca pedeaps complementar, ea se poate aplica pentru orice infraciune pentru care pedeapsa principal aplicat este de minim doi ani. Ca msur de siguran, ea se poate aplica cu rol preventiv, chiar dac nc nu exist o condamnare a farmacistului, dar acesta este incapabil, nepregtit etc., punnd n pericol societatea sau existnd un risc important de a svri fapte penale. Aplicarea pedepsei interzicerii exercitrii profesiunii farmacistului aflat n una din situaiile prezentate n lucrare este pe deplin justificat deoarece fapta acestuia prezint un pericol social crescut, periclitnd valorile sociale i ordinea de drept, acionnd n sens opus scopului nsui al farmacistului, de ocrotire a sntii i vieii omului. Cauzele de apariie a incompatibilitilor sunt: lipsa unor prevederi legale speciale privind proprietatea asupra unitilor farmaceutice; funcionarea necorespunztoare a organelor specializate ale Ministerului Sntii i ale organizaiilor profesionale implicate, n privina controlului respectrii condiiilor legale i a sanciunilor legale aplicabile; deficiene n respectarea eticii profesionale medicale i farmaceutice. Legislaia din domeniul farmaceutic romnesc nu este ndeajuns de bine studiat, structurat i aplicat, este deficitar pentru anumite probleme, inadecvat pentru altele i incoerent. Pentru o bun desfurare a activitilor farmaceutice i pentru diminuarea pericolului acestora pentru sntatea public, este necesar att ca legislaia din domeniul farmaceutic s fie cunoscut i aplicat corect, ct i ca aceast legislaie s fie armonioas i adaptat la nevoile sistemului actual de sntate.

REFERINE SELECTIVE

1. Crian Ofelia, Profesiunea de farmacist Probleme de legislaie, Ed. Medical Universitar Iuliu Haieganu, Cluj-Napoca, 2007, p. 18 - 127;

2. Legea nr. 81 din 9 mai 1997 privind exercitarea profesiunii de farmacist, nfiinarea, organizarea i funcionarea Colegiului Farmacitilor din Romnia, Monitorul Oficial, Partea I, nr. 89 din 14 mai 1997;

3. Legea nr. 305 din 28 iunie 2004 privind exercitarea profesiunii de farmacist, precum i organizarea i funcionarea Colegiului Farmacitilor din Romnia, Monitorul Oficial, Partea I, nr. 578 din 30 iunie 2004;

4. Legea nr. 95 din 14 aprilie 2006 privind reforma n domeniul sntii, Monitorul

10

Oficial, Partea I, nr. 372 din 28 aprilie 2006; 5. Murean Anamaria, Crian Ofelia, Polinicencu C., Exercitarea fr drept a profesiunii

de farmacist, Clujul Medical, 2004, 1, p. 162 165 6. Ordonana de urgen a Guvernului Romniei nr. 152 din 14 octombrie 1999 privind

produsele medicamentoase de uz uman, Monitorul Oficial, Partea I, nr. 508 din 20 octombrie 1999;

7. Murean Anamaria, Crian Ofelia, Polinicencu C., Interdicii de exercitare a profesiunii de farmacist, Farmacia, 2005, 4, p. 112 120;

8. Murean Anamaria, Crian Ofelia, Polinicencu C., Incompatibiliti n exercitarea profesiunii de farmacist, Farmacia, 2005, 5, p. 136 141;

9. DEX, Dicionarul explicativ al limbii romne, Ediia a II-a, Ed. Univers Enciclopedic, Bucureti, 1996;

10. Crian Ofelia, Profesiunea de farmacist - Probleme de legislaie, Ed. Medical Universitar Iuliu Haieganu, Cluj-Napoca, 2001, p. 69 80;

11. Ordinul Ministrului Sntii nr. 626 din 11 septembrie 2001 pentru aprobarea Normelor privind nfiinarea i autorizarea unitilor farmaceutice, precum i a Condiiilor de organizare i funcionare a acestora, Monitorul Oficial, Partea I, nr. 629 din 8 octombrie 2001;

12. Ordinul Ministerului Sntii nr. 679 din 16 iulie 2003 pentru aprobarea Reglementrilor privind clasificarea pentru eliberarea produselor medicamentoase de uz uman, Monitorul Oficial, Partea I, nr. 556 din 1 august 2003;

13. Legea nr. 266 din 7 noiembrie 2008 farmaciei, Monitorul Oficial, Partea I, nr. 765 din 13 noiembrie 2008, republicare Monitorul Oficial, Partea I, nr. 448 din 30 iunie 2009;

14. Crian Ofelia, Legislaia privind eliberarea medicamentelor n Romnia, n volumul Farmacistul furnizor de servicii de sntate, Ed. Medical Universitar Iuliu Haieganu, Cluj-Napoca, 2003, p. 24 - 34;

15. Colegiul Farmacitilor din Romnia, Filiala Cluj, Legislaie farmaceutic, vol. I, Codul de etic i deontologie al farmacitilor din Romnia, Tipografia Universitii de Medicin i Farmacie Iuliu Haieganu, Cluj-Napoca, 1998, p. 74 - 80;

16. Colegiul Farmacitilor din Romnia, Filiala Cluj, Legislaie farmaceutic, vol. I, Statutul Colegiului Farmacitilor din Romnia, Tipografia Universitii de Medicin i Farmacie Iuliu Haieganu, Cluj-Napoca, 1998, p. 51 - 59;

17. Colegiul Farmacitilor din Romnia, Filiala Cluj, Legislaie farmaceutic, vol. I, Regulamentul de organizare i funcionare al Colegiului Farmacitilor din Romnia, Tipografia Universitii de Medicin i Farmacie Iuliu Haieganu, Cluj-Napoca, 1998, p. 60 - 73;

18. Decizia Colegiului Farmacitilor din Romnia nr. 2 din 15 iunie 2009 privind aprobarea Statutului Colegiului Farmacitilor din Romnia i a Codului deontologic al farmacistului, Monitorul Oficial, Partea I, nr. 490 din 15 iulie 2009;

19. Ministerul Justiiei, Codul penal, Codul de procedur penal, Ed. Lumina Lex, Bucureti, 1997, p. 59 61;

20. Criu C., Codul juristului - Codul penal, Ed. Juris Argenssis, 2000, p. 535 - 654; 21. Legea nr. 143 din 26 iulie 2000 privind combaterea traficului i consumului ilicit de

droguri, Monitorul Oficial, Partea I, nr. 362 din 3 august 2000; 22. Constituia Romniei, Monitorul Oficial, Partea I, nr. 233 din 21 noiembrie 1991;

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Anamaria Muresan

Informaii personale

Nume/Prenume: Murean Anamaria Adres: Str. Cutezantei nr. 22/14, cod potal 540558, Tg.Mure, Romnia Telefon: +40 265 246 137 E-mail: badeami@yahoo.com Naionalitate: Romn Data naterii: 6 decembrie 1978 Ocupaia: farmacist

Experien profesional

Farmacist ef 09/2008 03/2009 Shoppers Drug Mart, Calgary, Canada

Farmacist ef 09/2007 08/2008 Rexall Drug Stores, Olds, Canada

Farmacist clinician 11/2006 08/2007 Foothills Hospital, Calgary, Canada

Farmacist (ocazional) 11/2006 08/2007 Rexall Drug Stores, Calgary, Canada

Farmacist comunitar 07/2006 11/2006 WalMart, Calgary, Canada

Farmacist comunitar i stagiar 04/2006 07/2006 Alberta Clinic Pharmacy, Calgary, Canada

Reprezentant regional 01/2004 01/2005 Montero, Cluj-Napoca, Romnia

Farmacist comunitar i stagiar 11/2003 12/2003 Arnica, Cluj-Napoca, Romnia

Farmacist comunitar i stagiar 07/1999 01/2005 Novofarm, Tg.Mures, Romnia

Abiliti precis, srguinciaos, capacitate de nvare rapid i receptiv la schimbri, sociabil, spirit de echip, dinamic i inovatoare

Educaie 1998 2003 Diplom de licen n Farmacie Universitatea de Medicin i Farmacie Iuliu Haieganu Cluj-Napoca, Facultatea de Farmacie, Romnia 1993 1997 Diplom de bacalaureat - profilul bilingv Englez-Francez Colegiul Alexandru Papiu Ilarian , Tg.Mure, Romnia

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Calificri profesionale

Certificat de prim ajutor i resuscitare cardio-pulmonar/ defibrilare extern automatizat nivel - furnizori de asisten medical, 01/2009

Autorizaie de administrare a medicamentelor pe cale injectabil acordat de Colegiul Farmacitilor Alberta, 12/2007

Diabetes Patient Care Level 1 Certificate Program, 09/2009 Women's Health Certificate Program, 09/2009 Obesity Certificate Program, 04/2008

Participri la manifestri tiinifice

Pharmacist Conference, Shoppers Drug Mart/Pharmaprix, Calgary, Canada, 2008 Summit 07 Expedition To Excellence, Katz Group, Toronto, Canada, 2007 The 24th Annual Calgary Therapeutics Course, The University of Calgary, Calgary,

Canada, 2007 Demystifying Hospital Pharmacy, Calgary Health Region, Calgary, Canada, 2006 Sesiunea poster - Interdicii de exercitare a profesiunii de farmacist, Congresul

Universitii de Medicin i Farmacie Iuliu Haieganu Cluj-Napoca, Romnia, 2003

Sesiunea de comunicri tiinifice - Exercitarea fr drept a profesiunii de farmacist, Congresul Studenilor Farmaciti, Ed. a III-a, Cluj-Napoca, Romnia, 2003

Concursul Aptitudini clinice, Congresul naional al studenilor farmaciti, Cluj-Napoca, Romnia, 2003

Concursul Comunicarea cu pacientul, Congresul naional al studenilor farmaciti, Cluj-Napoca, Romnia, 2000 and 2002

Publicaii

Murean Anamaria, Crian Ofelia, Polinicencu C., Interdicii de exercitare a profesiunii de farmacist, Farmacia, 2005, 4, p. 112 - 120

Murean Anamaria, Crian Ofelia, Polinicencu C., Incompatibiliti n exercitarea profesiunii de farmacist, Farmacia, 2005, 5, p. 136 - 141

Murean Anamaria, Crian Ofelia, Polinicencu C., Exercitarea fr drept a profesiunii de farmacist, Clujul Medical, 2004, 1, p. 162 - 165

Apartenen profesional

Colegiul Farmacitilor Alberta Asociaia Farmacitilor Alberta Societatea American a Farmacitilor din Sistemul de Sntate Colegiul Farmacitilor Romnia

Competene de utilizare a calculatorului

Microsoft Office, Internet programe de gestiune pentru farmacii (Simplicity, PDX, Connexus, Nexssys, SCM,

Centricity, HealthWatch)

Limbi strine cunoscute

Romn fluent Englez fluent Francez intermediar Italian conversaional

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THE IULIU HAIEGANU UNIVERSITY OF MEDICINE AND PHARMACY CLUJ-NAPOCA

THE FACULTY OF PHARMACY THE DEPARTMENT OF PHARMACEUTICAL ORGANIZATION

AND LEGISLATION

THE CRIMINAL LIABILITY IN THE PHARMACEUTICAL DOMAIN

SUMMARY OF THE PhD THESIS

Scientific Coordinator PhD Candidate Professor Constantin Polinicencu, PhD Pharmacist Anamaria Murean

2010

TABLE OF CONTENTS

INTRODUCTION..................................................................................................4

I. THE GENERAL PART. THE JURIDICAL LIABILITY .............................6

CHAPTER 1 THE CONCEPT OF LIABILITY ...................................................................6

1. 1. The definition and the forms of liability.................................................6 1. 2. The conditions of liability.......................................................................7 1. 3. Conclusions.............................................................................................9

CHAPTER 2 THE CRIMINAL LIABILITY ......................................................................10

2. 1. The definition of criminal liability........................................................10 2. 2. The principles of criminal liability .......................................................12 2. 3. The criminal offense .............................................................................18

2. 3. 1. Essential and general aspects of the criminal offense.............19 2. 3. 2. The elements of the criminal offense......................................20

2. 4. The sanction..........................................................................................25 2. 5. The execution of criminal sanctions .....................................................27

2. 5. 1. The execution of the main sentences ......................................28 2. 5. 2. The execution of the complementary sentences .....................30 2. 5. 3. The execution of the auxiliary sentences ................................30

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2. 6. Conclusions...........................................................................................30

CHAPTER 3 THE REHABILITATION AND THE CAUSES THAT DISMISS THE CRIMINAL LIABILITY ........................................32

3. 1. The rehabilitation..................................................................................32 3. 1. 1. The lawful rehabilitation.........................................................33 3. 1. 2. The court rehabilitation...........................................................34

3. 2. The causes that dismiss the criminal liability .......................................35 3. 2. 1. The amnesty............................................................................36 3. 2. 2. The pardon ..............................................................................37 3. 2. 3. The prescription ......................................................................38 3. 2. 4. The lack of former complaint and the reconciliation of the parties........................................................................................38

3. 3. Conclusions...........................................................................................39

II. PERSONAL CONTRIBUTIONS THE CRIMINAL LIABILITY IN THE PHARMACEUTICAL DOMAIN........................................................40

A. THE WORKING HYPOTHESIS..................................................................40 CHAPTER 4 PROBLEMS IN THE FARMACEUITCAL PRACTICE...........................40

4. 1. Problems that need to be legislated.......................................................42 4. 2. Problems that require changes to the laws in force .............................47 4. 3. Problems in the application of the laws in force...................................48 4. 4. Conclusions...........................................................................................49

B. MATERIALS AND METHODS...................................................................50 CHAPTER 5 THE PHARMACEUTICAL LEGISLATION AND THE JURIDICAL METHODS ............................................................50

5. 1. Materials ...............................................................................................50 5. 2. Methods ................................................................................................54

5. 2. 1. Metods of juridical research....................................................55 5. 2. 1. 1. The logical method ...............................................55 5. 2. 1. 2. The comparative method........................................55 5. 2. 1. 3. The historical method ............................................56 5. 2. 1. 4. The sociological method ........................................57

5. 2. 2. The juridical interpretation .....................................................58 5. 2. 2. 1. The grammatical method .......................................58 5. 2. 2. 2. The systematic method ..........................................59 5. 2. 2. 3. The logical method ................................................61 5. 2. 2. 4. The teleological method.........................................62 5. 2. 2. 5. The historical method ............................................63

5. 3. Conclusions...........................................................................................64

C. RESULTS AND DISCUSSIONS THE CRIMINAL LIABILITY REGARDING THE LEGAL FRAMEWORK OF THE PRACTICE OF PHARMACY ..................................................................65

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CHAPTER 6 THE ILLEGAL PRACTICE OF PHARMACY ..........................................67

6. 1. The dispensation from the druggist shop of other medicines than the those not requiring a medical prescription..............................79 6. 2. The functioning of the pharmaceutical units without a pharmacist......85 6. 3. The practicing of pharmacy outside the pharmaceutical unit ...............86 6. 4. Conclusions...........................................................................................89

CHAPTER 7 INTERDICTIONS TO PRACTICE PHARMACY .....................................91

7. 1. Criminal offenses against humanity and life ........................................91 7. 1. 1. Criminal offenses against peace and mankind........................93 7. 1. 2. Criminal offenses against life .................................................97

7. 2. Other criminal offenses that can lead to the interdiction of practicing pharmacy.............................................................................99 7.3. The suspension or revocation of the membership of the Romanian Colege of Pharmacists .......................................................105 7. 4. Conclusions.........................................................................................110

CHAPTER 8 THE INCOMPATIBILITIES OF PRACTICING PHARMACY ............111

8. 1. The distribution and the selling of other products than those registered and approved by the Ministry of Health...................112 8. 2. The practice of medicine.....................................................................113 8. 3. Occupations that can harm the dignity of the pharmacist profession or the morality.....................................................................................117 8. 4. Inadequate state of health ...................................................................118 8. 5. Incompatibilities under the Pharmacist's Code of Ethics ...................119 8. 6. Conclusions.........................................................................................123

III. FINAL CONCLUSIONS ............................................................................126

REFERENCES...................................................................................................134

Key Words: criminal liability, pharmacist, profession, criminal offense, interdiction, incompatibility.

INTRODUCTION

The paper studies the criminal liability in the pharmaceutical domain in Romania. We have chosen this topic because the criminal offense in the pharmaceutical domain is directed against the most important social value protected by the state through its laws the health. The pharmacists mission is to protect the health, to help in regaining it, but committing a criminal offense in this domain means to act against his own professional mission. In order to accomplish the purpose of this paper, it is necessary to analyze the legal conditions of the practice of pharmacy, the general drugs regulations and the special narcotics regulations. The present study refers in particular to the criminal liability derived from the conditions of the practice of

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pharmacy.

I. THE GENERAL PART. JURIDICAL LIABILITY

Chapter 1 The concept of liability

Every law field has its own particular kind of liability characterised by specific conditions of substance and form (conditions, modes of establishing, forms of achievement, mod, and sanctions). Thus, there are more forms of juridical liability: political liability (constitutional responsibility of the parliament), civil liability, criminal liability, administrative liability (liability of public power), disciplinary, international responsibility. The juridical liabilitys conditions are: unlawful conduct, guilt and the causal link between unlawful act and the damage caused.

Chapter 2 The criminal liability

Criminal law, overall, is structured around three fundamental institutions: criminal offense, criminal liability and punishment. Criminal liability represents the criminal justice constraint report, born as a result of criminal offense, between the state, on one hand, and the offender, on the other hand. This is a comprehensive report, whose contents form the state law, as the societys representative, to hold the offender accountable, to apply penalties for the offense and to compel him to execute it, and also the delinquents obligation to be liable for the offense and to subject himself to sanction, in order to reinstate law and order and to restore the laws authority.

The principle of criminal liability is the criminal offense the act that has a high degree of social danger, committed with guilt and established by the criminal law. Its elements are: the object, the subject, objective and subjective side. The enforcement of criminal sanctions is done by committing the defendant to accomplish the actual content of these sanctions.

Chapter 3 The rehabilitation and the causes that dismiss the criminal liability

The conviction may have some consequences after the execution of the main sentences, restricting the legal capacity of former convicts (forfeitures, interdictions and inabilities), but which may cease after a time through rehabilitation. Thus, rehabilitation is an incentive for former convicts to have the appropriate conduct required by society, proven by their compliance with the law. Through rehabilitation, the former convict is reintegrated into society, not only morally, but also legally. The causes that dismiss the criminal liability are: the amnesty, the pardon, the prescription, no prior complaint, the reconciliation of the parts and the withdrawal of the prior complaint. These causes are general, because in principle they relate to any offense. Some are effective only under the provisions of Criminal Code, while others, in some cases (amnesty or pardon), imply the intervention of the supreme organs of the state power.

II. PERSONAL CONTRIBUTIONS CRIMINAL LIABILITY IN THE PHARMACEUTICAL DOMAIN

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A. THE WORKING HYPOTHESIS

The criminal liability in the pharmaceutical domain is engaged due to the violation of the laws that govern the practice of pharmacy and the regulations of the drugs. Initially, at the start of this study, we tried to analyze both cases. In time, however, to maintain the order and the functionality of the paper we considered to limit our research to the first situation. Therefore, the objectives of this study are:

- the presentation of juridical liability under Romanian law; - the definition of criminal liability and the principles that govern it; - the presentation of the legal framework of pharmacy practice; - the establishment of legal norms, appropriate for the proposed research, the

ones leading to the initiation of the criminal liability in the pharmaceutical domain, especially those of exercising the pharmacist profession;

- the analysis of the text of these laws to determine where the criminal liability is engaged as a result of failure to follow the legal rules that govern the pharmacist profession;

- the study of the interdictions and incompatibilities of practicing pharmacy; - the identification of the conditions and the causes that lead to the illegal

practice of pharmacy; - the analysis of actual situations of illegal practice of pharmacy; - the identification and the analysis of the deficiencies of the text of the studied

laws, the problems in the application of these laws, the discordances between the different laws governing the pharmaceutical domain, but also the divergence between the legal provisions and the requirements in practice;

- the prevention of the recurrence of the examined problems in the future standards.

Chapter 4 Problems in the pharmaceutical practice

The Romanian pharmaceutical legislative problems can be classified into three categories: problems that need to be legislated, problems that require changes to the laws in force and problems in the application of the laws in force. Among the major issues in the practice of pharmacy that require regulation is the absence of a precise definition of the pharmacy profession, of pharmaceutical units ownership and of pharmaceutical units standards of operation.

The problems that require changes to the existing legislation related to the practice of pharmacy are multiple. Some are given by the existence of contrary rules in the text of the same law or in other legal provisions (e.g. art. 634 with art. 836 of the Law no. 95/2006), some from the lack in the legislation of the references provided (e.g. art. 562 of the Law no. 95/2006), and others do not have correspondence or reciprocity in the existing legislation (e.g. art. 563 par. 1 let. a and art. 383 let. a of the Law no. 95/2006). The problems in the application of the laws in force are due to: the lack of clear standards for pharmacy practice and the operation of the pharmaceutical units, too frequent pharmaceutical law changes in the last few years, and difficulties in the control of this activity regarding the application of the laws in force. The aim of this paper is to study the norms that engage the criminal liability in the pharmaceutical domain, with special regards to pharmacy practice, and to prevent

18

the legal problems observed and discussed to arise in a subsequent legal norm.

B. MATERIALS AND METHODS

Chapter 5 The pharmaceutical legislation and the juridical methods

For the proposed research we studied the law texts regarding the pharmacist profession, the organization and the functioning of the Romanian College of Pharmacists, the Code of Ethics and the Criminal Code of Romania.

The research of the laws governing the pharmaceutical domain requires the use of juridical methodology, ie the methods used in the law field of scientific research. We have presented the juridical research methods used, detailing the logical, comparative, historical and sociological methods. For the study proposed we have applied the juridical interpretation. It includes several categories of methods: grammatical interpretation, teleological, systematical, historical and logical. In general, in the present paper, these methods of juridical interpretation were not used in isolation, but were used together, two or more, or all at once, to establish the true meaning and purpose of the norms studied.

C. REZULTATE I DISCUII THE CRIMINAL LIABILITY REGARDING THE LEGAL FRAMEWORK OF

THE PRACTICE OF PHARMACY

Chapter 6 The Illegal Practice of Pharmacy

The analysis of the legal setting for the practice of pharmacy has led to the identification of the conditions under which the criminal offense of illegal practice of pharmacy is commited, as well as to the observation of the causes of committing this criminal offense. The conditions for the existence of this crime are derived from the committal of acts rezerved for the practice of pharmacy by a person who does not have this quality (art. 40 of Law no. 81/1997, art. 78 of Law no. 305/2004, art. 634 of Law no. 95/2006 and art. 281 of the Criminal Code). The actual situations of illigal practice of pharmacy are: - the dispensation from the druggist shop of other medicines than those not requiring

a medical prescription; - the functioning of the pharmacy or the drugs warehouse without a pharmacist; - the practice of pharmacy by a person who doesnt have this quality. The most frequent situations of illegal practice of pharmacy, encountered in practice, are those in which the pharmacy assistants, in druggist shops, break the regulations of group A drugs dispensation. The persons guilty of complicity in the criminal offense of illegal practice of pharmacy are most frequently pharmacists. The causes of the illegal practice of pharmacy are: - the lack of a precise definition, in a legislative measure, of the profession of

pharmacy and of the pharmacy assistant, their attributions, duties and professional competencies;

- the lack of clear legal provisions for the pharmacist intern; - the inadequate organising and functioning of the Pharmacy Inspection in

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monitoring the compliance with the legal requirements and the legal penalties applicable;

- the inefficiency of the activity of the Romanian College of Pharmacists regarding the compliance by the pharmacists with the Pharmacist Code of Ethics;

- the lack of professional conscience for some pharmacists. Considering the characteristics that define the profession and the societal values

protected by the state, we can deduce the importance of respecting the legal provisions related to the practice of pharmacy, because the criminal offense of illegal practice of pharmacy by a person who doesnt have the quality or by any other person other than the one satisfying the statutory requirements, may lead not only to the endangerment of the social values that the law protects by criminalizing such acts, but also to the compromise of the prestige of the profession which is the basis for its autonomy and self regulation.

Chapter 7 Interdictions of practicing pharmacy

The penalty of the interdiction of practicing pharmacy has been set successively by art. 5 of Law no. 81/1997, art. 10 of Law no. 305/2004 and art. 562 of Law no. 95/2006. This penalty may be imposed to the pharmacist by the professional organization as a disciplinary sanction or by the court following the final conviction for wilfully committing a crime against humanity or life in circumstances relating to the practice of pharmacy, as a complementary sentence (according to art . 53 par. 2 let. a, art. 64 let. c, art. 65 and art. 66 of the Criminal Code) for any offense for which the principal penalty imposed is at least two years, as an accessory sentence (according to art. 64 let. c and art. 71 let. b of the Criminal Code) for any offense for which the penalty imposed was any length of detention time, a safety measure (art. 111, 112 and 115 of the Criminal Code) for any offense even if no penalty was applied or following the challenge in court of the decisions of the professional organization.

Applying the penalty of the interdiction of practicing pharmacy to the pharmacist, found in one of the situations presented in the paper, is fully justified because his act has a high social danger, threatening social values and legal order, acting in the opposite purpose of the pharmacist himself, to protect health and human life.

Chapter 8 The incompatibilities of practicing pharmacy

The incompatibilities of practicing pharmacy were set successively by art. 6 par. 1 and 2 of Law no. 81/1997, art. 11 par. 1 of Law no. 305/2004 and art. 563 par. 1 of Law no. 95/2006.

Today, according to art. 563 par. 1 of Law no. 95/2006, the practice of pharmacy is incompatible with: the practice of medicine, any occupation that can harm the dignity of the pharmacist profession or the morality, and, according to the Pharmacist's Code of Ethics, with inadequate physical or mental health for practicing pharmacy.

The incompatibility between the practice of pharmacy and the practice of medicine, provided by Law. 95/2006, should be reformulated so as to establish consistent rules for the needs of practice. Although not required by Law no. 95/2006 and has not been provided in previous laws, the most common case of incompatibility

20

still remains one in which a person has engaged in the profession of medicine, while being the owner of a pharmaceutical unit. To prevent infringement to the patient right to choose the pharmacy, the provisions should be modified in the sense of acknowledging this incompatibility.

The incompatibility with any other profession or occupation liable to harm the dignity of the profession of pharmacy or morality, provided by art. 563 par. 1 let. b of Law no. 95/2006, is justified and is due to features derived from these professions or occupations, which would harm the relationship with the patient, either by lowering the patient's confidence in the pharmacist, either through an attitude contrary to fostering the health.

The incompatibility of practicing pharmacy with the pharmacists inadequate physical or mental health, provided by art. 563 par. 1 let. c of the Law. 95/2006 arises, in this case, on one hand, from the fact that a poor state of health of the person in question leads to failure in satisfying the legal conditions for the validity of the College of Pharmacists of Romania membership certificate (art. 564 par. 3 let. b of Law no. 95/2006) and the conditions of exercising the profession (art. 560 par. 1 let. b of Law no. 95/2006), and on the other hand, a poor state of health challenges the ability of the pharmacist to exercise correctly the profession for the benefit of the patients. A problem in this regard is the lack, in the present law, of a working procedure for referral to proper experts, to expertise and to issue the decision to suspend or withdraw the right to exercise the profession of pharmacy for the pharmacist in question.

The causes of the incompatibilities are: - the lack of specific legal provisions on the ownership of pharmaceutical units;

the poor functioning of the specialized institutions of the Ministry of Health and of the professional organizations involved in the monitoring of compliance with legal requirements and the legal applicable penalties;

- deficiencies in medical and pharmaceutical compliance with professional ethics. The provisions of art. 37 let. c, e and f of the Pharmacist Code of Ethics should

be reformulated or repealed, to be consistent with current pharmaceutical legislation.

III. FINAL CONCLUSIONS

This paper studies the norms on criminal liability in the pharmaceutical domain, with special regard to the practice of pharmacy. The working hypothesis is the legal issues in pharmaceutical domain, which can be classified into three broad categories: problems that need to be legislated, problems that require changes to the laws in force and problems in the application of the laws in force. For the proposed research we have studied the following legal and regulatory texts: Law no. 81/1997 on the practice of pharmacy, establishment, organization and functioning of the Romanian College of Pharmacists, Law no. 305/2004 on the practice of pharmacy, and the organization and functioning of the Romanian College of Pharmacists, Law no. 95/2006 on healthcare reform, Title XIV on the practice of pharmacy, organization and functioning of the Romanian College of Pharmacists, the Pharmacist Code of Ethics and the Criminal Code. The research of the pharmaceutical legislation requires the use of the legal methodology, of which the methods of legal interpretation and the comparative method were especially applied. These methods were applied to the legal provisions concerning the illegal practice of pharmacy, the interdictions to practice pharmacy and to the

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incompatibilities with the practice of pharmacy. The actual situations of illegal practice of pharmacy are: the dispensation from the druggist shop of other medicines than those not requiring a medical prescription, the functioning of the pharmacy or the drugs warehouse without a pharmacist, the practice of pharmacy by a person who doesnt have this quality. The causes of the illegal practice of pharmacy are: the lack of a precise definition, in a legislative measure, of the profession of pharmacy and of the pharmacy assistant, their attributions, duties and professional competencies, the lack of clear legal provisions for the pharmacist intern, the inadequate organising and functioning of the Pharmacy Inspection in monitoring the compliance with the legal requirements and the legal penalties applicable, the inefficiency of the activity of the Romanian College of Pharmacists regarding the compliance by the pharmacists with the Pharmacist Code of Ethics, the lack of professional conscience for some pharmacists. The penalty of the interdiction to practice pharmacy may be imposed to the pharmacist by the professional organization as a disciplinary sanction or by the court. It is mandatory to be applied by the court for final convictions for intentionally committing a crime against humanity or life in circumstances relating to the practice of pharmacy. As a complementary sentence, it is applicable to any offense for which the principal penalty imposed is at least two years. As a safety measure, it can be applied with a preventive role, although the pharmacist is not yet convicted, but he is incapable, unprepared, etc., endangering the society or if there is a significant risk of committing criminal acts. Applying the penalty of the interdiction to practice pharmacy to the pharmacist, found in one of the situations presented in the paper, is fully justified because his act has a high social danger, threatening social values and legal order, acting in the opposite purpose of the pharmacist himself, to protect health and human life. The causes of the incompatibilities are: the lack of specific legal provisions on the ownership of pharmaceutical units, the poor functioning of the specialized institutions of the Ministry of Health and of the professional organizations involved in the monitoring of compliance with legal requirements and the legal applicable penalties, deficiencies in the medical and pharmaceutical compliance with professional ethics. Romanian pharmaceutical legislation is not sufficiently well studied, structured and implemented, is insufficient for some problems, inappropriate and inconsistent for others. For a good conduct of pharmaceutical activities and to reduce their threat to the public health, it is necessary that the pharmaceutical law to be known and applied correctly and that such legislation is harmonized and adapted to the current health system needs.

SELECTIVE REFERENCES

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24. Legea nr. 81 din 9 mai 1997 privind exercitarea profesiunii de farmacist, nfiinarea, organizarea i funcionarea Colegiului Farmacitilor din Romnia, Monitorul Oficial, Partea I, nr. 89 din 14 mai 1997;

25. Legea nr. 305 din 28 iunie 2004 privind exercitarea profesiunii de farmacist, precum i organizarea i funcionarea Colegiului Farmacitilor din Romnia, Monitorul Oficial, Partea I, nr. 578 din 30 iunie 2004;

26. Legea nr. 95 din 14 aprilie 2006 privind reforma n domeniul sntii, Monitorul

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Oficial, Partea I, nr. 372 din 28 aprilie 2006; 27. Murean Anamaria, Crian Ofelia, Polinicencu C., Exercitarea fr drept a

profesiunii de farmacist, Clujul Medical, 2004, 1, p. 162 165 28. Ordonana de urgen a Guvernului Romniei nr. 152 din 14 octombrie 1999

privind produsele medicamentoase de uz uman, Monitorul Oficial, Partea I, nr. 508 din 20 octombrie 1999;

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33. Ordinul Ministrului Sntii nr. 626 din 11 septembrie 2001 pentru aprobarea Normelor privind nfiinarea i autorizarea unitilor farmaceutice, precum i a Condiiilor de organizare i funcionare a acestora, Monitorul Oficial, Partea I, nr. 629 din 8 octombrie 2001;

34. Ordinul Ministerului Sntii nr. 679 din 16 iulie 2003 pentru aprobarea Reglementrilor privind clasificarea pentru eliberarea produselor medicamentoase de uz uman, Monitorul Oficial, Partea I, nr. 556 din 1 august 2003;

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37. Colegiul Farmacitilor din Romnia, Filiala Cluj, Legislaie farmaceutic, vol. I, Codul de etic i deontologie al farmacitilor din Romnia, Tipografia Universitii de Medicin i Farmacie Iuliu Haieganu, Cluj-Napoca, 1998, p. 74 - 80;

38. Colegiul Farmacitilor din Romnia, Filiala Cluj, Legislaie farmaceutic, vol. I, Statutul Colegiului Farmacitilor din Romnia, Tipografia Universitii de Medicin i Farmacie Iuliu Haieganu, Cluj-Napoca, 1998, p. 51 - 59;

39. Colegiul Farmacitilor din Romnia, Filiala Cluj, Legislaie farmaceutic, vol. I, Regulamentul de organizare i funcionare al Colegiului Farmacitilor din Romnia, Tipografia Universitii de Medicin i Farmacie Iuliu Haieganu, Cluj-Napoca, 1998, p. 60 - 73;

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Anamaria Muresan

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Personal Information

Surname/Name: Anamaria Muresan Address: 22/14 Cutezantei st, Tg. Mures, 540558, Romania Phone: +40 265 246 137 Email: badeami@yahoo.com Nationality: Romanian Date of Birth: December 6, 1978 Occupation: pharmacist

Professional experience

Pharmacy manager 09/2008 03/2009 Shoppers Drug Mart, Calgary, Canada

Pharmacy manager 09/2007 08/2008 Rexall Drug Stores, Olds, Canada

Hospital pharmacist 11/2006 08/2007 Foothills Hospital, Calgary, Canada

Relief pharmacist 11/2006 08/2007 Rexall Drug Stores, Calgary, Canada

Community pharmacist 07/2006 11/2006 WalMart, Calgary, Canada

Community pharmacist and pharmacy intern 04/2006 07/2006 Alberta Clinic Pharmacy, Calgary, Canada

Regional representative 01/2004 01/2005 Montero, Cluj-Napoca, Romania

Community pharmacist and pharmacy intern 11/2003 12/2003 Arnica, Cluj-Napoca, Romania

Community pharmacist and pharmacy intern 07/1999 01/2005 Novofarm, Tg.Mures, Romania

Skills Accurate, diligent and quick worker Fast learner and receptive to changes Peoples person and team player Dynamic and innovative

Education 1998 2003 Bachelor of Science in Pharmacy Iuliu Haieganu University of Medicine and Pharmacy, Pharmacy Faculty, Cluj-Napoca, Romania, Diploma: The Criminal Liability in the Pharmaceutical Domain1993 1997 Baccalaureate in English and French Alexandru Papiu Ilarian College, Tg.Mure, Romania

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Professional qualifications

Certified in Standard First Aid and CPR/AED level HCP, 01/2009 Authorized by ACP to administer drugs by injection, 12/2007 Diabetes Patient Care Level 1 Certificate Program, 09/2009 Women's Health Certificate Program, 09/2009 Obesity Certificate Program, 04/2008

Participations Pharmacist Conference, Shoppers Drug Mart/Pharmaprix, Calgary, Canada, 2008 Summit 07 Expedition To Excellence, Katz Group, Toronto, Canada, 2007 The 24th Annual Calgary Therapeutics Course, The University of Calgary, Calgary,

Canada, 2007 Demystifying Hospital Pharmacy, Calgary Health Region, Calgary, Canada, 2006 Poster Session - The Interdictions of Practicing Pharmacy Situations from

Practice, Iuliu Haieganu University of Medicine and Pharmacy Congress, ClujNapoca, Romania, 2003

Scientific Communication Session with the paper entitled The Illegal Practice of Pharmacy, Cluj-Napoca, Romania, 2003

Clinical Abilities competition, The National Congress of Pharmacy Students, ClujNapoca, Romania, 2003

Communicating with the patient competition, The National Congress of Pharmacy Students, Cluj-Napoca, Romania, 2000 and 2002

Publications

The Incompatibilities Of Practicing Pharmacy, Farmacia (The Journal of the Romanian Society of Pharmaceutical Science), Romania, 2005

The Interdictions Of Practicing Pharmacy, Farmacia, Romania, 2005 The Illegal Practice Of Pharmacy, Clujul Medical (The Journal of the University

of Medicine and Pharmacy Iuliu Hatieganu), Romania, 2004

Professional memberships

Alberta College of Pharmacists Alberta Pharmacists Association American Society of Health-System Pharmacists Romanian College of Pharmacists

Computer knowledge

office software (Microsoft Office), Internet various programs used in pharmacies for dispensing (Simplicity, PDX, Connexus,

Nexssys, SCM, Centricity, HealthWatch)

Languages Romanian fluent English fluent French intermediate Italian conversational